# SAN: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

- Device class: 2; regulation: 21 CFR 866.1650; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 468 days (middle half 166–686)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2024: 4
- 2025: 1
- 2026: 3

## Most-cited predicates
- K211815: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (2024), cited by 2
- K230675: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (2024), cited by 1
- K241324: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (2024), cited by 1
- K221688: ASTar BC G- Kit and ASTar Instrument (2024), cited by 1

Source page: https://510kreport.com/product-code/SAN
Data by year (CSV): https://510kreport.com/product-code/SAN.csv